A Comparative study of effects of melatonin and alprazolam on the quality of sleep in patients posted for elective surgery - prospective randomised control study

Introduction

Pre-operative sleep disturbances can affect healthy patients who otherwise do not have chronic sleep issues or medical conditions. These disturbances can be triggered by the stress and anxiety associated with the anticipation of surgery, fear of anaesthesia and concerns of the outcome of surgery, leading to difficulty falling asleep or staying asleep**.** The unfamiliar hospital environment, if patients are required to stay overnight, can worsen sleep disturbances. Alprazolam, a benzodiazepine that acts by enhancing the effects of gamma aminobutyric acid  is used as a pre anaesthetic medication, primarily due to its anxiolytic and sedative properties. A common dose for preoperative anxiety is 0.25 mg to 0.5 mg of alprazolam on the night before surgery. The dose depends on the patient age, medical history, and the level of anxiety. Melatonin is a hormone that plays a key role in regulating the sleep wake cycle. It is naturally produced by the pineal gland in the brain in response to darkness, promoting sleepiness and helping to regulate circadian rhythms. Beyond sleep regulation, melatonin has mild anxiolytic effects, which can help alleviate pre operative anxiety. The typical dose of melatonin for preanesthesia medication ranges from 0.5 mg to 3 mg. Unlike benzodiazepines like midazolam or alprazolam, melatonin does not carry the same risks of dependency or withdrawal, making it a safer option.

 Primary objective

To compare the effects of melatonin and alprazolam on the quality of sleep in patients posted for elective surgery

 Secondary objective

To assess the pre operative anxiety in both the groups

State inclusion criteria

Patients aged 18 to 59 years with the American Society of Anaesthesiologists physical status Classes 1 and 2, posted for various elective surgeries.

State exclusion criteria

Patients with OSA

Patients with history of insomnia and on insomnia medication

Pregnant women

Patients with any mental illness

Patients on steroids and antipsychotics

Trauma patients

Following written informed consent, they will be randomised into one of the two groups, Alprazolam group A and Melatonin group M. Randomisation will be done by the lot system. A baseline assessment of quality of sleep and anxiety will be done on all patients using the GSQS and STAI 6.

Patients in group A will receive Tablet Alprazolam 0.25 mg orally and and patients of group M will receive Tablet Melatonin 3mg at 10pm night before their elective surgery.

Patients will be instructed to refrain from the caffeinated drinks, screen time and follow their routine sleep schedule.

On the morning of the surgery, the quality of sleep in the night before, will be assessed by the Groningen Sleep Quality Scale GSQS and the anxiety levels will be assessed by the State Trait Anxiety Inventory 6 STAI 6 scale.

Patients with a GSQS score of 0 to 2 will be considered to have had a good quality sleep, 3 to 5 as with mild sleep disturbances, 6 to 9 as moderate sleep disturbances and 10 to 15 as severe sleep disturbances.

Patients STAI 6 Anxiety score, after reversing the positively worded items, summing the scores, and standardization to 20 to 80 score, patient with score 20 to 39 will be considered as Low anxiety, 40 to 59 as Moderate anxiety and 60 to 80 as High anxiety